Clinical Study of TBF Regimen in Allo-HSCT in Patients With CNS Leukemia

Launched by FIRST AFFILIATED HOSPITAL XI'AN JIAOTONG UNIVERSITY · Dec 26, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with central nervous system (CNS) leukemia who are preparing for a specific type of stem cell transplant called allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study is comparing a treatment regimen known as TBF with a traditional approach called modified BuCY2 to see if TBF can help these patients live longer and have better outcomes after their transplant. Thiotepa, one of the drugs in the TBF regimen, can cross into the brain and has effects similar to radiation, which may benefit patients with leukemia that has spread to the brain.

To participate in this trial, patients should be aged between 14 and 60 and have been diagnosed with CNS leukemia based on specific medical criteria, such as symptoms affecting the brain or spinal fluid abnormalities. They need to have a good performance status, meaning they can carry out daily activities relatively well. It’s important to note that the trial is not yet recruiting participants, and those who might be interested will need to provide informed consent to join. If you or a loved one meet these criteria, this trial could offer an opportunity to explore a possibly more effective treatment for CNS leukemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients diagnosed with central nervous system leukemia by MICM meet one of the following conditions: corresponding symptoms and signs of central nervous system involvement; cerebrospinal fluid pressure increased by 200 mm water column; the white blood cell count in cerebrospinal fluid was 0.01×10\^9/L; cerebrospinal fluid protein qualitative test was positive or protein quantification was 45 mg/dL; leukemic cells can be found in the cerebrospinal fluid; cranial imaging suggested central involvement.
• • Aged 14-60 years, male or female.
• • KPS score: ≥80.
• • Signed the informed consent.
• Exclusion Criteria:
• • Patients intending to receive autologous hematopoietic stem cell transplantation.
• • Patients with transplantation contraindications.
• • Those who refuse to sign the informed consent form.